Medical Device Software Engineer

Job Summary

Seeking a full-time Medical Device Software Engineer to work remotely, who will develop new medical device software, ensure cybersecurity compliance, and collaborate on regulatory documentation for FDA submissions.

Key responsibilities

• Participate in the design and development of medical device software, writing clean and efficient code while meeting regulatory standards
• Guide clients through cybersecurity risk analysis and threat modeling, ensuring systems comply with FDA requirements
• Collaborate with regulatory professionals to create technical documents that align with FDA guidance and validate software safety

Required qualifications

• PhD, Master's, or Bachelor's degree in Computer Science, Biomedical Engineering, or a related field
• 3+ years of experience in a full-time software engineering role
• Proficiency in coding with Python, C++, or TypeScript
• Familiarity with AI tools as productivity enhancers
• Willingness to travel 2-3 times a year for client visits and company retreats